BDEP: Home-based transcranial direct current stimulation in bipolar depression
Overview
Bipolar disorder is a common and disabling. Currently the most common treatments are mood stabilising or antipsychotic medications and talking therapies. However, after a full course of treatment with antidepressant medication or psychotherapy, over one third continue to be unwell. As well, for many individuals, they would prefer to not take mood stabilising or antipsychotic medications or be involved in a talking therapy.
Transcranial direct current stimulation (tDCS) is a non-invasive form of brain stimulation, and studies have shown that tDCS could be a possible treatment for bipolar depression. tDCS produces a small electric current (2 mA) which affects how easily brain cells can discharge. The tDCS device is a headset with two metal discs, called electrodes, that sit on the top part of the forehead. One is for where the current is generated and one for where the current goes back to the device.
In this study we want to build on from our previous research to see how effective tDCS is for the treatment of bipolar depression.
What is the purpose of the study?
We recently completed a study with 174 participants with major depression. We found that participants who received the active tDCS sessions showed a greater improvement in their depressive symptoms as compared to participants who had the inactive tDCS sessions. The tDCS device was the same for both groups, but one was active and the other one was inactive, and all sessions were at home.
We have also completed a study in 44 participants with bipolar depression where everyone received the active tDCS treatment. Now we want to see how effective the active tDCS treatment is for participants with bipolar depression, when compared to the inactive tDCS sessions.
What does participation involve?
We are looking for 212 individuals with bipolar depression to take part in our trial.
Using a random allocation process, half of the participants will receive the active tDCS sessions for 10 weeks, as well as continuing their usual treatment, and half will receive and inactive tDCS sessions as well as continuing their usual treatment. Neither the research team or the participants will know which treatment they are receiving. All sessions can be provided at home
All participants will have some initial telephone and video calls to talk about the study and to ask about your health.
Are you interested in taking part in this study?
Planned end date
30 Nov 2027 11:49Conditions
Bipolar DisorderPeople types
Adult 18+Inclusion Criteria
1. Adults aged 18 years or over
2. Diagnosis bipolar disorder in a current depressive episode based on Diagnostic and Statistical Manual of Mental
Disorders, Fifth Edition (DSM-5) criteria assessed by structured clinical assessment, Mini-International
Neuropsychiatric Interview (MINI) (Sheehan et al., 1998)
3. Having at least a moderate severity of depressive symptoms as measured by a score of at least 18 in MADRS
(Montgomery and Åsberg, 1979)
4. Being medication-free, or taking medication (e.g. mood stabilising medication), or in psychotherapy for at least 6
weeks prior to enrolment
5. Being under care of GP and / or community mental health service
6. Agreeable for GP to be regularly informed by research team about participation
7. Able to provide written, informed consent
Exclusion Criteria
1. Significant suicide risk as measured by answering 'yes' to questions 4, 5 or 6 on the Columbia Suicide Severity
Rating Scale (C-SSRS) Screen (Posner et al., 2011)
2. Primary comorbid psychiatric disorder (e.g. obsessive compulsive disorder) based on DSM-5 criteria as assessed
in MINI (Sheehan et al., 1998)
3. Having a Young Mania Rating Scale (Young et al., 1978) score of 20 or more.
4. Current daily use of medications that affect cortical excitability (e.g. benzodiazepines)
5. Current heavy alcohol use with high risk of alcohol use disorder as measured by a score of > 5 in Alcohol use
disorders identification test consumption (AUDITC) (Khadlesari et al., 2017; NICE, 2023)
6. History of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), cranial electrotherapy
stimulation (CES), transcranial direct current stimulation (tDCS), deep brain stimulation (DBS), other brain stimulation,
or psychosurgery for depression
7. History of esketamine / ketamine for treatment of depression
8. Medical disorder that may mimic mood disorder (e.g. hormonal disorder)
9. History of myocardial infarction, coronary artery bypass graft (CABG), coronary heart failure (CHF), or history of other
cardiac issues
10. Have cognitive impairment (e.g. dementia)
11. History of a neurological disorder (e.g., cerebrovascular events, stroke, structural lesion, epilepsy, seizures,
Parkinson's disease)
12. History of migraines or intractable headaches
13. Implant in brain, neurocranial defect or active implantable medical device
14. Shrapnel or any ferromagnetic material in head
15. Concurrent enrolment in another interventional study